Tablets Capsules

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32 March 2017 Tablets & Capsules
Patheon, based in Durham, NC, is
a leading CDMO that operates
worldwide and provides a full menu
of services to the pharmaceutical
industry, including formulation, API
supply, finished dosage manufactur-
ing, and packaging. Its site in
Mississauga, ON, Canada, has long
been a repository of the company's
solid dosage expertise, particularly
for high-potency products.
For nearly 30 years, the site relied
on a GKF 1200 tamping-style encap-
sulator to manufacture clients' capsule
products. "There were no major issues
with the operation of that machine,"
said Michael Murray, the manager of
process pharmacy. "It's a tank and ran
well, but it wasn't too sensitive to deli-
cate operations and it wasn't con-
tained." But that didn't pose a prob-
lem, Murray said. "We were managing
without it by using pneumatic con-
trols, gravity feed, and other devices
to contain the products."
Nonetheless, when a client asked
whether Patheon would consider
upgrading the capsule filling opera-
tion, the company reassessed. "The
client was satisfied with what we
were doing but was concerned with
the long-term containment of the
product if we grew into volume with
it," Muarry said. "This is a client that
does very well with containing their
products that are high potency.
They're class-leading. So it was per-
haps a reflection of themselves that
they wanted to assist us in acquiring
a machine that could better contain
this particular product for the safety
of our operators."
Because the GKF 1200 was reliable
and because of SUPAC requirements,
Patheon sought to replace it with a
similar tamping-style machine. To
evaluate the options, the company sent
user-requirement specifications (URS)
to three vendors, including Bosch
Packaging Technology, Minneapolis,
MN, which won the business. "Not
many companies do tamping-style
encapsulators, and Bosch is probably
the premier supplier so the selection
was easy," Murray said.
Tight fit
Patheon chose Bosch's GKF
HiProTect 1700 encapsulator for use
in commercial production and a
Bosch GKF Protect 702 encapsulator
for use by colleagues in its Product
Development Services (PDS) group.
The GKF 1700, designed and built
for containment, keeps operators iso-
lated from the product while it oper-
ates and during maintenance and
cleaning. It fills as many as 100,000
capsules per hour with powders or
pellets and can be equipped to han-
dle micro-tablets, liquids, and combi-
nation fills. The machine's check-
weigher adjusts capsule fill weights as
it works to keep products on-spec.
After Bosch built the larger
machine, Murray and his colleague
Nick Walsh spent a week in Stuttgart,
Germany, to attend factory-accep-
tance tests. The equipment was then
shipped to Mississauga, where the
smaller machine had arrived 8 months
earlier and was in use by PDS.
But the larger machine couldn't be
installed until Patheon made some
upgrades to overcome severe space
constraints. "Our site in Mississauga is
at its limit in terms of building out-
ward, and that presented some chal-
lenges in designing the room and
then getting all the accessories and
auxiliaries that are required for this
machine into the appropriate areas,"
Murray said, including a dust collec-
tor and a wash-in-place (WIP) sys-
tem. Those and other auxiliary equip-
ment were installed on an upper level,
with the Bosch machine below.
"The dust collector is designed to
be on an outside wall, but because we
couldn't go out any further on
Patheon's property, we had to build
within," Walsh said. That meant
changing four different design features
of the dust collectors to make it explo-
Patheon's Bosch's GKF HiProTect 1700 encapsulator will begin commercial pro-
duction this summer. The company's Mississauga site also installed a Bosch GKF
Protect 702 encapsulator for use by its PDS group.
Patheon installs
Bosch contained
capsule filler, first in
North America
I N D U S T R Y
a p p l i c a t i o n